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Cardiovascular Kidney Metabolic SyndromeCKMS RegistryNCT07718789

Cardiovascular-Kidney-Metabolic Syndrome Registry

An observational study of Cardiovascular Kidney Metabolic Syndrome, run by Centre for Chronic Disease Control, India.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

The goal of this observational registry study is to learn about cardiovascular-kidney-metabolic syndrome, also called CKMS, among adults receiving care at tertiary care hospitals in India. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Kidney Metabolic Syndrome
How many people
2,250 participants
Where
No sites listed yet
Study dates
24 Jul 2026to 31 Dec 2027
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults receiving care at the outpatient departments of Cardiology and Internal Medicine at participating tertiary care hospitals in India who have Cardiovascular-Kidney-Metabolic Syndrome (CKMS) or CKMS-related risk factors and are managed under routine clinical practice. Eligible participants will be consecutively enrolled after providing written informed consent.

Who may be able to join

  • Adults ≥18 years visiting select tertiary care hospitals AND
  • Presenting with signs and/or symptoms of CKMS :
  • 2.1. Adiposity i.e., Body Mass Index > 23, and/or large waist circumference [women: ≥ 80 cm; men: ≥ 90 cm] AND/OR 2.2. Metabolic syndrome i.e., new or a known case of hypertension, type-2 diabetes, dyslipidaemia, chronic kidney disease, and/or PCOS.
  • AND/OR 2.3. Presenting with signs of subclinical CVD and/or with a history of clinical CVD with metabolic syndrome AND
  • Willing and able to provide informed consent.

Who cannot join

  • Stage 0 CKMS i.e., a healthy state characterized by normal body weight, absence of metabolic risk factors such as hypertension, type-2 diabetes, dyslipidemias, preserved kidney function with no evidence of CKD, and no subclinical or clinical manifestations of CVDs.
  • Neuro-cognitive, psychiatric, or any surgical conditions which prevents in obtaining reliable clinical data.
  • Any surgical and/or medical condition that is likely to prevent the participant from complying with the requirements of the study or completing the study.
  • Participants already taking part in another clinical trial.
  • Pregnant and/or lactating women.

About this study

The goal of this observational registry study is to learn about cardiovascular-kidney-metabolic syndrome, also called CKMS, among adults receiving care at tertiary care hospitals in India. CKMS describes the close relationship between excess body weight, metabolic conditions such as high blood pressure and diabetes, kidney disease, and cardiovascular disease.

The main questions this study aims to answer are:

Read more
  • What proportion of participants are in each stage of CKMS when they enter the study?
  • How do participants' CKMS stage and related health factors change over 12 months?
  • How does participants' quality of life change over time?
  • What are the prescription practices for CKMS?

Participants will:

  • Provide information about their general health, medical history, lifestyle, current medicines, family history, and quality of life.
  • Have measurements taken, including height, weight, waist circumference, and blood pressure.
  • Provide blood and urine samples for tests related to blood sugar, cholesterol, kidney function, inflammation, and heart health.
  • Undergo an electrocardiogram, also called an ECG, and a coronary artery calcium scan according to the study schedule.
  • Return for follow-up visits at 6 months and 12 months after joining the study. Participants will continue to receive their usual medical care as decided by their treating doctor. No experimental medicine or treatment will be provided as part of this study.

This multi-centre registry will include approximately 2250 adults from five tertiary care hospitals in India. The information collected will help researchers understand the burden, progression, risk factors, quality of life, and treatment patterns of CKMS in India.

Read the detailed description

Cardiovascular-Kidney-Metabolic Syndrome (CKMS) framework proposed by the American Heart Association to recognize the interconnected relationship between metabolic disorders, chronic kidney disease, and cardiovascular disease. Rather than considering these conditions independently, the CKMS framework emphasizes their shared pathophysiology and progressive nature, highlighting the need for integrated risk assessment and management across the disease spectrum.

India is experiencing a rapid rise in obesity, hypertension, type 2 diabetes mellitus, dyslipidaemia, chronic kidney disease, and cardiovascular disease. These conditions frequently coexist and contribute substantially to morbidity, mortality, and healthcare expenditure. Despite this growing burden, existing surveillance systems and disease registries primarily focus on individual diseases, resulting in fragmented information that limits understanding of how cardiovascular, kidney, and metabolic disorders interact and progress over time.

The absence of comprehensive real-world data on CKMS represents an important evidence gap in India. Understanding the distribution of CKMS stages, associated clinical characteristics, healthcare utilization, treatment practices, and longitudinal changes in disease status is essential for informing clinical practice, strengthening preventive strategies, and supporting healthcare policy. A multicentre registry provides an opportunity to systematically collect standardized clinical information from routine care settings and evaluate CKMS within the Indian healthcare context. Prospective observational registry of adults receiving routine clinical care to assess CKMS staging, progression, management, and outcomes without assignment of study interventions.

This registry has been established to generate prospective, real-world evidence on CKMS across tertiary care hospitals in India. Information collected through the registry will facilitate characterization of the CKMS spectrum, including demographic and clinical profiles, anthropometric measures, cardiometabolic risk factors, renal function, cardiovascular status, laboratory parameters, medication use, and patient-reported quality of life. Longitudinal follow-up will enable assessment of changes in disease stage and clinical characteristics during routine clinical care.

The registry is designed to reflect routine clinical practice without influencing treatment decisions. All diagnostic investigations, treatment decisions, and follow-up care will be performed according to the treating physician's clinical judgment and local standard of care. Participation in the registry will not require any experimental intervention or modification of routine medical management.

Data will be collected using standardized electronic case report forms within a secure REDCap database to ensure consistency across participating centres. Standardized operating procedures, investigator training, built-in data validation rules, centralized data monitoring, and routine quality assurance processes will be implemented to promote data completeness, accuracy, and consistency. Participant confidentiality will be maintained through coded study identifiers, restricted database access, secure storage systems, and compliance with applicable ethical, regulatory, and institutional data protection requirements.

The findings from this registry are expected to establish one of the first comprehensive multicentre datasets describing CKMS in the Indian population. The resulting evidence will improve understanding of the epidemiology and clinical profile of CKMS, support identification of high-risk populations, describe contemporary management practices, and provide a foundation for future observational studies, implementation research, clinical trials, and evidence-based strategies aimed at reducing the burden of cardiovascular, kidney, and metabolic diseases in India.

Keywords
Cardiovascular-Kidney-Metabolic Syndrome (CKMS), Cardiovascular Disease, Cardiometabolic Health, Chronic Kidney Disease, Type 2 Diabetes Mellitus, Hypertension, Hyperglyceridaemia, Obesity, CKMS Staging, Registry
Medical subject headings
Cardiovascular Diseases, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Hypertension, Hypertriglyceridemia, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07718789
Study groupRoleWhat they receive
Adults with Cardiovascular-Kidney-Metabolic Syndrome (CKMS)Adults aged 18 years or older with Cardiovascular-Kidney-Metabolic Syndrome (CKMS) or CKMS-related risk factors who meet the study eligibility criteria and provide informed consent. Participants will receive routine clinical care and will be prospectively observed to assess CKMS staging, clinical characteristics, risk factors, prescription practices, quality of life, and disease progression over time. No study-specific intervention will be assigned.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stage-wise proportion of participants with Cardiovascular-Kidney-Metabolic Syndrome (CKMS) at Baseline

    Measured: 6 months

Secondary outcomes (5)
  1. Stage-wise proportion of participants with CKMS at six-months and 12-months.

    Measured: 12 months

  2. Change in CKMS staging among participants at six-months and 12-months.

    Measured: 12 months

  3. Mean change in key clinical parameters (BMI, anthropometric measurements, BP, HbA1c, lipid profile, cardiac markers, eGFR, and ECG) at six-months and 12-months.

    Measured: 12 months

  4. Quality-of-life assessment using the EQ-5D-5L questionnaire at baseline, six-months, and 12-months.

    Measured: 12 months

  5. To capture prescription practices for CKMS.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study start24 Jul 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
2,250 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07718789
Sponsor's protocol ID
CCDC_RID_2025_09
Acronym
CKMS Registry
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because the registry contains confidential participant-level health information. De-identified, aggregated study results will be reported through scientific publications and presentations in accordance with applicable ethical, regulatory, sponsor, and institutional policies.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Kidney Metabolic Syndrome, run by Centre for Chronic Disease Control, India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage-wise proportion of participants with Cardiovascular-Kidney-Metabolic Syndrome (CKMS) at Baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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